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Tuesday, September 02, 2008

CA E-Pedigree: Going to ... 2015

Sorry, Spinal Tap fans. Implementation of California’s e-pedigree law has (probably) been pushed back to 2015. Only 2,312 days to go!

Nevertheless, advocates of a secure supply chain should not feel stuck in a hell hole. The widespread industry support for the bill makes me believe that the 2015 date might actually stick. The more realistic timeline should encourage pharmaceutical manufacturers to get serious about mass serialization for their products – a necessary first step for California’s vision of serialized e-pedigree.

Thus, I expect that “mass serialization” will become increasingly important for supply chain security efforts at multinational drug makers, especially given the new serialization requirements in countries such as Belgium, Italy, and Turkey. However, it's still not clear whether global standards will lead us to “serialize” or “serialise.” (Full disclosure: I am on the Advisory Board of leading serialization vendor Secure Symbology.)

Tonight I’m Gonna Stop You Tonight

The new CA timeline comes from SB1307, a bill sponsored by CA state Senator Mark Ridley-Thomas and passed by the state assembly on August 19 by a vote of 58-1. Technically, the bill still needs to be signed by Governor Schwarzenegger to become law in California.

Here are the new deadlines for compliance:

Manufacturers: 50% of product lines serialized by January 1, 2015; 100% by January 1, 2016

“All vested parties, including consumer protection advocates and pharmaceutical manufacturers and distributors have reached resolution and have identified a reasonable and workable solution that will allow additional time and flexibility to comply with current requirements.”

I suggest that you read the official Senate Floor analysis for a good summary of the bill’s evolution. When you get to the bottom, you will be rewarded with a list of the 13 associations and 22 companies that formally supported SB1307. Curiously, only 2 of the big 3 drug wholesalers are listed. Que pasa, AmerisourceBergen (ABC)?

Note that SB1307 clears the way for a Federal approach to serialized e-pedigree by setting strong federal pre-emption language. As you may know, I support a federal approach to the pharmaceutical supply chain – see my op-ed Securing America’s Pharmaceutical Supply Chain. I’ll have more to say on the Federal situation tomorrow.

As I write this today (9/2), I believe this bill is not yet law - pending some action (or long enough inaction) by the Governor. Like many large states, California faces a serious budget deficit - the resolution of which creates some uncertainty on what will happen with this. Right now, manufacturers are in a tough position as the 1/1/2011 date is still on the books.

As an eventual end result, it would be much easier to comply with one national standard and compliance schedule rather than a myriad of state regulations.

Thanks once again for following this critical - and extremely costly - issue. Is there any current news on what is happening with other state laws?

California's budget deficit should make it more likely for SB 1307 to pass. As I noted earlier this tear, the CA Board of Pharmacy has a limited budget ($10 million) and had no personnel to implement or enforce the 2009 deadline prior to the delay to 2011. Moving the deadline to 2015 allows money to be allocated in a future budget -- and perhaps allows a federal solution to emerge that would take the pressure off CA.

One comment I can't beleive no one has made. What about the major companies that have embraced this, have moved off of a compliance strategy and focused on patient safety and a secure supply chain strategy.What about the countless number of people hours and dollars invested to meet the original CabOP deadline. CaBOP - sorry guys we were only kidding. Thanks for stepping up, spending your companies money, investing you time, caring about our not so noble cause - CABOP was only kidding. See you folks in 2015 - bring your pcket books and precisous time again or are we only kidding CABOP!

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